The Department of Health and Human Services Food and Drug Administration awarded a $350,000 definitive cost-no-fee contract to Elligo Health Research, Inc. to support the agency's Broad Agency Announcement seeking proposals to extend the value of common data model harmonization in generating clinical evidence from real world data sufficient to support regulatory use. The small disadvantaged business will perform work at locations in Silver Spring, Maryland under the contract addressing the...
<p>The Department of Health and Human Services Food and Drug Administration awarded a $411,646.00 Firm Fixed Price definitive contract to Putnam Data Sciences, LLC, a woman-owned small business, for a Learning Framework for Casual Effect Estimation using Real World Data. The contract was awarded on September 25, 2019 and has a completion date of March 27, 2022. The place of performance is Silver Spring, MD. No set-aside was used for this contract award.</p>
This contract was awarded by the Food and Drug Administration (FDA) to Deloitte Consulting LLP to develop standards for data quality and data sources that increase the quality, interoperability, and usability of real-world data. The award is for a total ceiling value of $46,892,963.80, with a completion date of September 27, 2025. The contract is a definitive, firm fixed-price contract with no set-aside designation.
As the prime contractor, Deloitte Consulting LLP has engaged several...
S-3 Research LLC was awarded a definitive firm fixed price contract valued at one hundred four thousand five hundred dollars by the Department of Health and Human Services Food and Drug Administration. The contract calls for the awardee to utilize big data, machine learning, and infoveillance approaches to detect and characterize adoption and adherence to pre-exposure prophylaxis therapy among minority populations. To be performed in Silver Spring, Maryland, the contract aims to provide...
The Department of Health and Human Services Food and Drug Administration awarded a Delivery Order contract to Information Innovators, LLC, a for-profit limited liability company, for an Electronic Records Retention Project. The contract was issued under the Enterprise System Lifecycle Management Support (ELMS) master IDIQ vehicle. The potential value of the contract is $924,859.41 and it is a Labor Hours contract type. The place of performance is Rockville, MD. This contract was not set aside...
This is a Firm Fixed Price delivery order awarded by the Food and Drug Administration (FDA), a civilian agency, to Eastern Research Group Inc., a for-profit Subchapter S corporation, for a study on "PATIENT EXPERIENCE DATA IN REGULATORY DECISION MAKING." The contract award, valued at $520,205.00, is associated with the FDA's Center for Drug Evaluation and Research (CDER) Priority Analysis indefinite delivery, indefinite quantity (IDIQ) contract vehicle. There is no set-aside...
The Department of Health and Human Services Food and Drug Administration awarded a definitive contract to Deloitte Consulting LLP, doing business as Deloitte, to implement the SHIELD-Harmonized Laboratory Data Standards in 6 active healthcare institutions. The contract has a potential value of $918,947.49 and was awarded on a labor hours pricing basis. No set-aside was utilized. The contract is focused on implementing data standards to support the FDA's mission. Key subcontractors include the...
<p>This is a $9,671,431.00 Firm Fixed Price contract awarded by the Food and Drug Administration (FDA), a civilian federal agency, to Safe Health Systems, Inc., a self-certified small disadvantaged business. The contract is for stimulating innovation in clinical evaluations and personalized medicine to improve product development and patient outcome. The contract has no set-aside designation and has an ultimate completion date of March 27, 2026.</p>
The Department of Health and Human Services' Food and Drug Administration (FDA) awarded a $1,275,361.26 definitive cost-no-fee contract to Alliance Nctn Foundation, a non-profit organization and foundation, to conduct the "Integrating Clinical Trials and Real World Endpoints Data (ICAREDATA) Data Capture and Standardization Study". This contract, with a performance period ending on September 29, 2024, is part of the FDA's broader efforts to advance regulatory science and support...
The U.S. Food and Drug Administration (FDA) awarded a $200,000 delivery order contract to Realm Research LLC, a minority-owned small disadvantaged woman-owned small business, to monitor the conduct and progress of extramural FDA-funded research studies in human subjects overseen by the Center for Drug Evaluation and Research (CDER). This contract is part of a larger $1.1 million indefinite delivery contract awarded to Realm Research in 2023 to provide broader scientific and clinical support...